Quality & complianceOfficial

BfArM publishes Elekta urgent field safety notice for MOSAIQ oncology information system

🇩🇪 BfArM field safety notices · Wed 28 Oct 2026

Germany's medicines and devices regulator has listed a manufacturer advisory on MOSAIQ, but the specific issue and required actions appear only in Elekta's attached notice.

The German Federal Institute for Drugs and Medical Devices (BfArM) has published an Urgent Field Safety Notice from Elekta Solutions AB covering its MOSAIQ Oncology Information System. The listing is dated 28 October 2026 and carries the reference number 50124/26.

BfArM files the item under the product group "Radiotherapy / Radiation protection - radiotherapy treatment planning systems". The regulator's entry does not describe the nature of the problem, the affected software versions or any corrective measures.

Instead, the listing directs readers to the enclosed Advisory Notice from the manufacturer for further information and device details. That document is provided as a 319KB PDF, which BfArM flags as not meeting accessibility standards.

As general context, a field safety notice is the communication a manufacturer sends to users when it takes a field safety corrective action for a medical device. Regulators such as BfArM publish these notices so that affected users can find them.

What it means for your team

  • Radiation oncology departments using MOSAIQ should obtain and read Elekta's full Advisory Notice to establish whether the notice applies to their installations and what action is required.
  • Quality and risk teams at affected sites should check that the notice has been logged and routed to the right internal owners, as the BfArM listing itself gives no detail on the issue.
  • Regulatory and vigilance staff should use reference 50124/26 to track the notice and any follow-up from Elekta or BfArM.

Official source: BfArM field safety notices ↗

Article written by VigiEye from the official source (BfArM field safety notices). AI-assisted; check the source before acting.

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